MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

K021988 · Medrad, Inc. · FRN · Aug 29, 2002 · General Hospital

Device Facts

• Record ID: K021988
• Device Name: MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
• Applicant: Medrad, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Device Story

Medrad Continuum MR Compatible Infusion System provides intravenous delivery of fluids and medications to patients undergoing Magnetic Resonance (MR) imaging. Device operates within MR environment; designed for use by trained medical staff including critical care, emergency room, and radiology nurses. System functions while stationary or mobile; supports infusion therapy immediately prior to, during, and after MR procedures. Device output assists clinicians in maintaining patient fluid/medication requirements during imaging. Benefits include continuous therapy without interrupting MR procedures or requiring patient transport to non-MR environments.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design specifications.

Technological Characteristics

MR-compatible infusion system; designed for operation in high-magnetic field environments. Includes infusion pump and intravascular administration set. Class II device (Product Codes: FRN, FPA).

Indications for Use

Indicated for patients requiring intravenous maintenance medications and fluids during MR procedures. Intended for use immediately before, during, and after MR procedures in stationary or mobile settings. Not for long-term care outside the MR environment. For use by trained medical staff (critical care, ER, radiology nurses).

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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# AUG 2 9 2002

Medrad, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K021988

Trade/Device Name: Medrad Continuum MR Compatible Infusion System Regulation Number: 880.5725 and 880.5440 Regulation Name: Infusion Pump and Intravascular Administration Set Regulatory Class: II Product Code: FRN and FPA Dated: August 23, 2002 Received: August 26, 2002

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Mosenkis

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot Direct Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Intended Use

## Indications for Use Statement

510(k) Number:

K021988

Device Name:

.

Medrad Continuum MR Compatible Infusion System

Indications for Use:

The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucuriti

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devi

510(k) Number: K621988

• Medrad, Inc. • 510(k) Premarket Submission • Medrad Continuum MR Compatible Infusion System . Response 1 Confidential .